Saving the Next Generation of Regulatory Scientists

I recently attended the China International Summit of Over-the-Counter (OTC) Industry Innovation and Development, in Boao, China. At that meeting, the annual sales of OTC products were reported to have grown by 17% in 2011, a disappointment to some of the participants benchmarking to a growth in prescription sales that exceeded 20%. In comparison, growth in sales of prescription products in the United States has slowed to only a few percent annually. I use these numbers simply to underline something that we know already—the structure of the pharmaceutical industry is globalizing, and fast. This change adds new stresses to an already stressed system, in which the regulatory structure of even one country can create impediments to the commercialization of new drugs.

The evolution of the Common Technical Document and other international standards and guidances have attempted to improve the path by harmonizing some aspects of the developmental requirements internationally. However, these efforts are not sufficient. First, the legal requirements for drug development in many countries are tied to monographs and standards in their respective pharmacopeias, and to amplify the problem, regulations may reference older versions of those pharmacopieas. Thus, each country can require that a company satisfy a regionally specific set of tests, greatly complicating a global marketing program.

Second, the industry depends on expert knowledge of a relatively restricted talent pool. Quality and regulatory departments are in many cases staffed at the highest levels by individuals who are approaching retirement, and even these folks may have limited international expertise. When they retire, companies will have great difficulty replacing them.

Since World War II, the US government has invested huge amounts of funds in research. The National Institutes of Health budget alone in fiscal year 2011 was about $30 billion. Almost every university with a medical school has a large graduate education program, with scholarships and fellowships for anatomists, molecular biologists, pharmacologists, and neuroscientists, all striving to discover the next breakthrough. By comparison, as admitted by the former Principal Deputy Commissioner of FDA at a PDA conference, Joshua Sharfstein, "Investing billions in the former (basic science) while starving the latter (regulatory science) is unbalanced, like a rower with a massive right arm and a puny left arm. It's no surprise that the result is not the forward movement we are all hoping for."

However, FDA is not in charge of US education. Other government agencies and groups have never been able to come to grips with the need to formalize education for those individuals who will take new discoveries to market. Perhaps this is because it has only recently become apparent that we desperately need a new generation of regulatory scientists, formulation engineers, GMP experts, and industrial manufacturing design engineers. Without these experts, we hobble the competitiveness of our industry.

When medical schools were formalized in response to the Flexner report of 1910 on the state of medical education in the US and Canada, planners looked at the skills and knowledge that would be needed to provide a suitable education in a systematic way. This approach makes sense to product developers. The process of education is in itself a product-development initiative, where the knowledge and experience of the student are designed and developed in a way that ensures their suitability to the role that they will eventually play in society. However, that kind of systematized approach has not been in evidence for translational science (as that part of product development between bench and bedside has come to be called).

What we do see is a small collection of graduate science programs that are run often as offshoots of extension or professional-development programs, without any continuing sources of revenue to support graduate students, and with little of the research funding or other support needed to ensure that faculty can be recruited and sustained in these key areas of national importance. Is it any wonder that our universities are filled with PhD students whose degrees are not suitable for transition to industry, yet were seduced into that path by the promise of graduate stipends? Is it any surprise that industry is reluctant to hire these individuals who may need considerable investment to remake them into the kinds of professionals required in today's highly competitive and fast-paced environment? We are led to an unfortunate dichotomy where industry complains that it cannot get enough trained individuals to meet its needs, yet unemployment rates from universities are distressingly high.

At the University of Southern California, we have had the opportunity to grow from about a dozen Masters of Science (MS) students 10 years ago to a full-fledged International Center for Regulatory Science, housing not only a large MS program in regulatory science but also a professional doctoral program, a new MS in the Management of Drug Development, and several professional certificates. We have had almost no evidence of unemployment for our graduates. My colleagues who direct regulatory and clinical programs at other universities have seen similar results, and we are now meeting annually to ensure the orderly development of this new profession. These useful, but expensive, MS programs in regulatory, quality, and clinical science provide baby steps in developing new professions that were barely acknowledged even a decade ago. Most of these programs educate those already in industry positions, their companies willing to help with tuition reimbursement. We need to do more to engage our current students who are disillusioned about today's employment outlook, to show them that good jobs do exist, and that academic programs are available to prepare them for industry jobs. In turn, these young people with this new-found expertise will invigorate our companies.

Innovation in pharmaceutical technology is crucial to reducing costs, increasing product safety, and minimizing drug shortages. To accomplish such challenging objectives, we must have an environment where techniques and standards are harmonized by individuals whose training and experience prepares them for careers in global pharmaceutical technology.

Only these individuals will be able to assist the improvement of testing, the development of standards, and the construction of thoughtful management methods. Our ability to put a better educational system in place is key to our competitive advantage. Perhaps the time is right to examine our educational structure to ensure that it is prepared to help young people enter the next global century, not the last nationally-focused one.

Frances J. Richmond, PhD, is a professor and director, Regulatory Science Program, School of Pharmacy, University of Southern California (USC), and director of the USC International Center for Regulatory Science.